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Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment

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ClinicalTrials.gov Identifier: NCT02152098
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Monika Lucia Bayer, Bispebjerg Hospital

Brief Summary:

Firstly, the investigators aim to study the biochemical, structural and functional changes associated with acute muscle strain injury in the acute phase and during rehabilitation in vivo. Specific factors present after the injury and their effects on connective tissue cells will be examined in vitro.

Secondly, the investigators will investigate individuals with chronic pain, scar tissue and inferior function after a previous muscle strain injury and test a specific rehabilitation program to alleviate pain and disabilities associated with the preceding muscle injury. The investigators have the following hypotheses:

  1. Humoral growth factors and pro-inflammatory macrophages released into the injured area post strain injury stimulate formation of connective tissue in vitro.
  2. Early onset of rehabilitation will be superior to a delayed start of rehabilitation for the healing process, in regards to structural improvement of tissue and better clinical function.
  3. Scar tissue following a muscle strain injury is characterized by disorganized structure of connective tissue.
  4. Mechanical loading in the form of heavy eccentric muscle activity for 12 weeks will lead to a local re-modeling of scar tissue, and result in improved function and reduced symptoms in patients with chronic pain and impaired function after a previous muscle injury.

Condition or disease Intervention/treatment Phase
Muscle Strain Procedure: Acute Early onset of rehabilitation Procedure: Acute Delayed onset of rehabilitation Procedure: Chronic Exercise Procedure: Chronic Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment
Study Start Date : April 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Chronic Exercise
Chronic Exercise
Procedure: Chronic Exercise
Exercise

Experimental: Acute Early onset of rehabilitation
Acute Early onset of rehabilitation
Procedure: Acute Early onset of rehabilitation
Early onset of rehabilitation

Experimental: Chronic control
Chronic control
Procedure: Chronic Control
Control

Experimental: Acute Delayed onset of rehabilitation
Acute Delayed onset of rehabilitation
Procedure: Acute Delayed onset of rehabilitation
Delayed onset of rehabilitation




Primary Outcome Measures :
  1. Return to full physical activity [ Time Frame: Baseline; Up to 30 weeks (estimated time frame maximum) ]
    First time the subject is fully fit to take part in all types of physical activity post injury;


Secondary Outcome Measures :
  1. Magnetic resonance images [ Time Frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 6 months ]
    Size of injured tissue; Size and location of hematoma; Measurement of muscle perfusion (indication of metabolic activity)

  2. Ultrasound images [ Time Frame: Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months ]
    Size and location of injury

  3. Ultrasound images [ Time Frame: Baseline, 1 week, 2 weeks ]
    Volume of hematoma

  4. Strength measurements [ Time Frame: Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months ]
    Strength tests of injured muscle group compared to healthy muscle group on contralateral leg

  5. Structural changes of tissue [ Time Frame: Baseline, 12 weeks ]
    Evaluation of tissue samples from injured muscle before and after rehabilitation program

  6. Aspiration and characterization of inter-/ intramuscular fluid in the injured muscle [ Time Frame: Baseline, 3 -14 days ]
    The aspirated fluid (hematoma/exudate) will be analyzed for released humoral factors, cell types present and its effect on human fibroblast proliferation


Other Outcome Measures:
  1. Pain score on the Visual Analog Scale [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks ]
    Each subject is asked to rate his/ her pain level on the Visual Analog Scale during each rehabilitation session at a pre-defined time points during the work-out.

  2. Injury screening questionnaire [ Time Frame: Baseline, 1,2,3,4,5,6,7,8,9,10,11,12 weeks, 6 and 12 months ]
    Each subject is asked to fill out a questionnaire to record the impact of the injury on his/her physical activity and activities of daily living.

  3. Rehabilitation registration [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks ]
    Each subject is asked to keep a regular training diary of his/ her rehabilitation progress.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute muscle strain injury
  • Chronic muscle strain injury
  • Age above 18 years

Exclusion Criteria:

  • Daily intake of non‐steroidal anti‐inflammatory drugs (NSAIDs) within three months prior to the injury
  • Smoking
  • Diabetes
  • Connective tissue and/or rheumatic diseases
  • Any observed organ dysfunctions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152098


Locations
Denmark
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, Building 8
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
University of Copenhagen

Responsible Party: Monika Lucia Bayer, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02152098     History of Changes
Other Study ID Numbers: MI-114
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Sprains and Strains
Wounds and Injuries